BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 3970466 · Received July 31, 2014

    Report

    Report Number
    1644487-2014-01902
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    July 8, 2014
    Report Date
    July 8, 2014
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON¿S PROGRAMMING SYSTEM WAS NOT WORKING WHILE IN THE OR. THE HANDHELD DEVICE AND PROGRAMMING WAND WERE RETURNED TO THE MANUFACTURER FOR ANALYSIS. THE PROGRAMMING WAND PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. ANALYSIS OF THE HANDHELD DEVICE IS CURRENTLY UNDERWAY.

    Description of Event or Problem · 1

    THE HANDHELD ANALYSIS WAS COMPLETED ON 08/07/2014. NO ANOMALIES ASSOCIATED WITH THE HANDHELD WERE NOTED DURING TESTING USING THE AC ADAPTER OR THE MAIN BATTERY WITH A FULL CHARGE. THE HANDHELD PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. ANALYSIS OF THE FLASHCARD WAS COMPLETED ON 08/07/2014. NO ANOMALIES ASSOCIATED WITH FLASHCARD SOFTWARE OR DATABASES WERE IDENTIFIED DURING THE FLASHCARD ANALYSIS. THE FLASHCARD AND SOFTWARE PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448133 PROGRAMMING SOFTWARE PROGRAMMING COMPUTER LYJ CYBERONICS, INC. MODEL 250 1077283

    Patients

    Seq Age Sex Outcome Treatment
    1